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There is no evidence that DMSO alters the course of any disease
or is, in any sense, a miracle drug. To suggest on the basis of the
evidence available to date, controlled or uncontrolled, that DMSO
is a major medical advance for any serious disease, let alone a
variety of such diseases, is misleading.
The work you have heard about on brain and spinal cord injury
is potentially important, but I would emphasize it is also at a very
early stage of clinical investigation. There are no control trials in
this area, and it is premature to draw conclusions on the basis of
this promising clearly early work.
This is not to deny, or be unsympathetic to, the potential of
DMSO to provide symptomatic relief for patients with certain pain-
ful disorders or the possibility that a new important use may yet
lie undiscovered.
The FDA is willing, indeed anxious, to approve DMSO for such
uses whenever controlled trials meeting the statutory standard are
available. We have worked in the past, and stand ready to work in
the future, with any party in developing protocols for such trials
and in expediting their review.
May I also comment that I noted in the course of the morning a
number of members in this committee expressed interest in consid-
ering legislation that would revise existing drug procedures under
the Food, Drug and Cosmetic Act.
I would like to point out that this administration has introduced
major legislation, called the Drug Regulation Reform Act of 1979,
that is currently submitted to both Houses as H.R. 4258 and
S. 1045.
This legislation constitutes the most extensive revision of food
and drug law in over 30 years, and proposed reforms in it include
those which would streamline the approval process for new drugs
and provide a mechanism for dealing with the sometimes difficult
problem of developing drugs which companies perceive as having
little commercial value.
This legislation reflects extensive joint efforts during the 95th
Congress between the Food and Drug Administration and the
House Subcommittee on Health. I would welcome the interest of
your committee in that legislation.
Mr. Chairman, thank you very much. I would be delighted to
answer questions.
The CHAIRMAN. Thank you, Doctor.
Doctor, what is the statute to which you refer, the statute that
establishes what must be shown for a drug to be recognized by
Food and Drug?
Dr. CROUT. The Food, Drug and Cosmetic Act, section 505. The
standard for effectiveness is "substantial evidence" of effectiveness
which means evidence derived from controlled clinical investiga-
tions conducted by experts qualified by scientific training and expe-
rience to evaluate the effectiveness of drugs.
The CHAIRMAN. Well, in the first place, the initiative must
always come from the person trying to get the drug approved, is
that right?
Dr. CROUT. Yes, sir.
The CHAIRMAN. You don't take any steps to try to accelerate the
presentation of acceptable testimony?
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